Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply…
Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 37630039300471 1 x EDA Module Kit GTIN : 37630039300426 1 x EmpowerSync® Power Supply GTIN : 37630039300839 1 x Injector GTIN : 37630039300822
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for EmpowerCTA®+ Injector System with EDA | Listed by | Bracco Injeneering, Switzerland |
| FDA product code | IZQ |
| Device type | Injector, Contrast Medium, Automatic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Record published | 2017-10-26 |
| Record revised | 2024-05-30 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Dry environment; Handling environment temperature -29 to 60 °C; Storage environment atmospheric pressure 10 to 110 KiloPascal; Handling environment humidity 0 to 85 % RH |
| Distribution end date | 2023-12-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.